On August 15, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported that ALX Oncology’s next generation CD47 blocker, evorpacept, has been selected for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer (Press release, ALX Oncology, AUG 15, 2022, View Source [SID1234618314]). Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody-drug conjugate ("ADC"), to determine the safety, tolerability and efficacy of this drug combination.
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"Patients with advanced breast cancer who develop resistance to therapies are in need of novel and tolerable treatment options," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are thrilled to partner with Quantum Leap, recognized as a leader in the development of research initiatives supporting new therapies, to accelerate the advancement of evorpacept in breast cancer. Moreover, this collaboration expands our solid tumor investigations with evorpacept in combination with an ADC. We believe the addition of evorpacept can improve ENHERTU’s anti-cancer activity without increasing toxicity."
The I-SPY-P1 TRIAL will be led by Paula Pohlmann, Associate Professor of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center. ALX Oncology will provide funding and supply evorpacept. As the study sponsor, Quantum Leap will be responsible for managing the trial.